Trial Outcomes & Findings for A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva (NCT NCT05299073)

NCT ID: NCT05299073

Last Updated: 2025-01-03

Results Overview

Area under the plasma concentration versus time curve from time zero to the last quantifiable concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 257 participants
• Primary outcome timeframe: Day 1 to Day 253
• Results posted on: 2025-01-03

Participant Flow

Participant milestones

Measure	MB09 (Denosumab Biosimilar) Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Overall Study STARTED	85	86	86
Overall Study COMPLETED	85	84	85
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Measure	MB09 (Denosumab Biosimilar) Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Overall Study Withdrawal by Subject	0	0	1
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva

Baseline characteristics by cohort

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09: Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered	Total n=255 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants	85 Participants n=7 Participants	85 Participants n=5 Participants	255 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	40.5 years STANDARD_DEVIATION 6.93 • n=5 Participants	38.8 years STANDARD_DEVIATION 6.59 • n=7 Participants	39.4 years STANDARD_DEVIATION 7.15 • n=5 Participants	39.5 years STANDARD_DEVIATION 6.90 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	85 Participants n=7 Participants	85 Participants n=5 Participants	255 Participants n=4 Participants
Race/Ethnicity, Customized Race & Ethnicity : White	85 participants n=5 Participants	85 participants n=7 Participants	85 participants n=5 Participants	255 participants n=4 Participants
Race/Ethnicity, Customized Race & Ethnicity : Not Hispanic or Latino	85 participants n=5 Participants	85 participants n=7 Participants	85 participants n=5 Participants	255 participants n=4 Participants
Region of Enrollment Poland	85 Participants n=5 Participants	85 Participants n=7 Participants	85 Participants n=5 Participants	255 Participants n=4 Participants
Body Mass Index	26.13 kg/m^2 STANDARD_DEVIATION 2.441 • n=5 Participants	25.76 kg/m^2 STANDARD_DEVIATION 2.344 • n=7 Participants	26.05 kg/m^2 STANDARD_DEVIATION 2.415 • n=5 Participants	25.98 kg/m^2 STANDARD_DEVIATION 2.396 • n=4 Participants
Weight	83.68 Kg STANDARD_DEVIATION 8.550 • n=5 Participants	82.74 Kg STANDARD_DEVIATION 8.334 • n=7 Participants	82.48 Kg STANDARD_DEVIATION 8.643 • n=5 Participants	82.97 Kg STANDARD_DEVIATION 8.492 • n=4 Participants
Height	179.07 cm STANDARD_DEVIATION 6.098 • n=5 Participants	179.20 cm STANDARD_DEVIATION 6.662 • n=7 Participants	177.72 cm STANDARD_DEVIATION 5.857 • n=5 Participants	178.66 cm STANDARD_DEVIATION 6.227 • n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 253

Population: Pharmacokinetic population includes subjects who received the study treatment, who did not have major protocol deviations, and had sufficient data to calculate primary PK endpoints.

Area under the plasma concentration versus time curve from time zero to the last quantifiable concentration

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
AUC0-last	146000 day*ng/mL Geometric Coefficient of Variation 26.8	134000 day*ng/mL Geometric Coefficient of Variation 27.4	138000 day*ng/mL Geometric Coefficient of Variation 24.1

PRIMARY outcome

Timeframe: Day 1 to Day 253

Population: Pharmacokinetic population includes subjects who received the study treatment, who did not have major protocol deviations, and had sufficient data to calculate primary PK endpoints.

Maximum observed plasma concentration

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Cmax	3240 ng/mL Geometric Coefficient of Variation 22.0	3100 ng/mL Geometric Coefficient of Variation 27.0	3090 ng/mL Geometric Coefficient of Variation 25.4

SECONDARY outcome

Timeframe: Day 1 to Day 253

Population: Pharmacokinetic population includes subjects who received the study treatment, who did not have major protocol deviations, and had sufficient data to calculate primary PK endpoints.

Area under the plasma concentration versus time curve from time zero extrapolated to infinity

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
AUC0-∞	147000 day*ng/mL Geometric Coefficient of Variation 26.9	136000 day*ng/mL Geometric Coefficient of Variation 27.4	139000 day*ng/mL Geometric Coefficient of Variation 24.3

SECONDARY outcome

Timeframe: Day 1 to Day 253

Population: Pharmacokinetic population includes subjects who received the study treatment, who did not have major protocol deviations, and had sufficient data to calculate primary PK endpoints.

Time to reach Cmax

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Tmax	10.00 day Interval 1.95 to 43.04	9.95 day Interval 3.02 to 27.99	9.99 day Interval 2.97 to 28.02

SECONDARY outcome

Timeframe: Day 1 to Day 253

Population: Pharmacokinetic population includes subjects who received the study treatment, who did not have major protocol deviations, and had sufficient data to calculate primary PK endpoints.

Clearance

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
CL	0.238 L/day Geometric Coefficient of Variation 26.9	0.258 L/day Geometric Coefficient of Variation 27.4	0.251 L/day Geometric Coefficient of Variation 24.3

SECONDARY outcome

Timeframe: Day 1 to Day 253

Population: Pharmacokinetic population includes subjects who received the study treatment, who did not have major protocol deviations, and had sufficient data to calculate primary PK endpoints.

Terminal half-life

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
t1/2	12.5 days Geometric Coefficient of Variation 38.6	12.1 days Geometric Coefficient of Variation 37.2	12.4 days Geometric Coefficient of Variation 37.6

SECONDARY outcome

Timeframe: Day 1 to Day 253

Population: Absolute sCTX concentrations below the limit of quantification were taken as ½ lower limit of quantification (LLOQ) for parameter estimation (LLOQ: 70.0 pg/mL).

Observed concentration of serum C-terminal telopeptide of Type 1 collagen (sCTX) parameter will be calculated as PD endpoint. AUC0-253: area under the plasma concentration versus time curve from time 0 to day 253

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Pharmacodynamics (sCTX) AUEC0-253	30000 day*ng/mL Geometric Coefficient of Variation 57.2	31800 day*ng/mL Geometric Coefficient of Variation 61.5	33400 day*ng/mL Geometric Coefficient of Variation 45.8

SECONDARY outcome

Timeframe: Day 1 to Day 253

Population: At each level of subject summarization, a subject is counted once for the most related event. Percentages are based on the number of subjects in the Safety Population within each treatment and overall.

A treatment-emergent adverse event is defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure.

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Incidence of Treatment Emergent Adverse Events (TEAEs) Any Grade 1 TEAE	4 Participants	3 Participants	5 Participants
Incidence of Treatment Emergent Adverse Events (TEAEs) Any Grade 2 TEAE	10 Participants	11 Participants	14 Participants
Incidence of Treatment Emergent Adverse Events (TEAEs) Any Grade 3 or higher TEAE	9 Participants	4 Participants	13 Participants
Incidence of Treatment Emergent Adverse Events (TEAEs) Any TEAE	18 Participants	17 Participants	28 Participants
Incidence of Treatment Emergent Adverse Events (TEAEs) Any serious TEAE	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 253

Population: Treatment-induced ADA positive (TIADA): includes subjects with only post-treatment positive ADA results. Overall: includes all subjects with any TIADA positive result at any time. Percentages are based on TIADA positive subjects in the Safety population within each treatment.

The incidence of ADA to denosumab and the neutralizing potential and titre of positive ADA.

The immunogenicity endpoint included denosumab anti-drug antibodies (ADA).

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=84 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=84 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=84 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Incidence of Anti-denosumab Antibodies (ADA) overall negative ADA	83 Participants	83 Participants	82 Participants
Incidence of Anti-denosumab Antibodies (ADA) overall positive ADA	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 253

The incidence the neutralizing potential and titre of positive ADA.

Outcome measures

Measure	MB09 (Denosumab Biosimilar) n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 Participants Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Incidence of Neutralizing Antibodies (NAb)	0 Participants	0 Participants	0 Participants

Adverse Events

MB09 (Denosumab Biosimilar)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

US-sourced Xgeva

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

EU-sourced Xgeva

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	MB09 (Denosumab Biosimilar) n=85 participants at risk Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 participants at risk Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 participants at risk Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Serious Adverse Event	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Psychiatric disorders Serious Adverse Event	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.

Other adverse events

Measure	MB09 (Denosumab Biosimilar) n=85 participants at risk Sterile vial 120mg/1.7mL, Single dose, 35mg SC MB09 (denosumab biosimilar): Single dose of 35mg SC administered	US-sourced Xgeva n=85 participants at risk Sterile vial 120mg/1.7mL, Single dose, 35mg SC US-sourced Xgeva: Single dose of 35mg SC administered	EU-sourced Xgeva n=85 participants at risk Sterile vial 120mg/1.7mL, Single dose, 35mg SC EU-sourced Xgeva: Single dose of 35mg SC administered
Investigations TEAE	8.2% 7/85 • Number of events 10 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	3.5% 3/85 • Number of events 3 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	14.1% 12/85 • Number of events 16 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Infections and infestations TEAE	7.1% 6/85 • Number of events 6 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	7.1% 6/85 • Number of events 9 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	7.1% 6/85 • Number of events 6 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Nervous system disorders TEAE	3.5% 3/85 • Number of events 4 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	2.4% 2/85 • Number of events 2 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	3.5% 3/85 • Number of events 3 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Injury, poisoning and procedural complications TEAE	1.2% 1/85 • Number of events 2 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	2.4% 2/85 • Number of events 2 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	3.5% 3/85 • Number of events 3 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Musculoskeletal and connective tissue disorders TEAE	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	3.5% 3/85 • Number of events 5 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Gastrointestinal disorders TEAE	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 3 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TEAE	2.4% 2/85 • Number of events 2 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Psychiatric disorders TEAE	1.2% 1/85 • Number of events 2 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Respiratory, thoracic and mediastinal disorders TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Skin and subcutaneous tissue disorders TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Blood and lymphatic system disorders TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
General disorders TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Metabolism and nutrition disorders TEAE	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Renal and urinary disorders TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Vascular disorders TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Nervous system disorders Treatment-Related TEAE	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Musculoskeletal and connective tissue disorders Treatment-Related TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 2 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.
Skin and subcutaneous tissue disorders Treatment-Related TEAE	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	1.2% 1/85 • Number of events 1 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.	0.00% 0/85 • Adverse events and SAEs were assessed for 36 weeks (during the duration of the study) and followed until they were resolved, stable, or judged by the investigator to be not clinically significant.

Additional Information

Susan Millan PhD

mAbxience Research S.L.U.

Phone: +34 917711500

Email: susana.millan@mabxience.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place